NCT00774761CompletedPhase 2
A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Dey1 site in 1 country97 target enrollmentStarted: November 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- Plasma AUC(0-t) after 1 week of dosing
Study Overview
Brief Summary
The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able to understand the requirements of the study and provide consent
- •Medical diagnosis of COPD
- •A current or prior history of at least 10-pack years of cigarette smoking
- •Female of child-bearing potential to use adequate birth control
Exclusion Criteria
- •Diagnosis of asthma
- •Other significant disease than COPD
- •Has donated a unit of blood within 30 days of study, or intends to donate
- •QTc greater than 0.460 seconds
- •Subjects who had radiation or chemotherapy in the previous 12 months
- •Subjects who had lung resection
- •History of illegal drug abuse or alcohol abuse within the past 5 years
Arms & Interventions
1
Experimental
Intervention: fluticasone propionate/formoterol fumarate (Drug)
2
Experimental
Intervention: fluticasone propionate/formoterol fumarate (Drug)
3
Active Comparator
Intervention: fluticasone propionate (Drug)
4
Active Comparator
Intervention: fluticasone propionate (Drug)
5
Active Comparator
Intervention: formoterol fumarate (Drug)
Outcomes
Primary Outcomes
Plasma AUC(0-t) after 1 week of dosing
Time Frame: PK sampling over 24 hrs
Secondary Outcomes
- FEV1(pre-dose and 2 hrs post-dose)
Investigators
Study Sites (1)
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